Efficacy and Safety of MK-1654 in Healthy Pre-term and Full-Term Infants

JRCT ID: jRCT2051210019

Registered date:07/05/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Respiratory syncytial virus infection
• Date of first enrollment: 08/06/2021
• Target sample size: 3300
• Countries of recruitment: US,Japan,Canada,Japan,Argentina,Japan,Brazil,Japan,Chile,Japan,Colombia,Japan,Mexico,Japan,Peru,Japan,Belgium,Japan,Czech Republic,Japan,Denmark,Japan,Finland,Japan,France,Japan,German,Japan,Israel,Japan,Italy,Japan,Poland,Japan,Romania,Japan,Turkey,Japan,South Africa,Japan,UK,Japan,China,Japan,South Korea,Japan,Malaysia,Japan,Philippines,Japan,Thailand,Japan
• Study type: Interventional
• Intervention(s): Participants receive an intramuscular injection of MK-1654 or placebo at Day 1.

Outcome(s)

Primary Outcome

-The incidence of RSV-associated Medically attended lower respiratory infection (MALRI) (outpatient and inpatient) from Days 1 through 150 postdose.
-Solicited injection-site AEs from Days 1 through 5 postdose.
-Solicited daily body temperature with fever.
-Solicited systemic AEs from Days 1 through 5 postdose.
-Anaphylaxis/hypersensitivity AESI from Days 1 through 42 postdose.
-Rash AESI from Days 1 through 42 postdose.
-Nonserious AEs from Days 1 through 42 postdose.
-SAEs through the duration of study participation.

Secondary Outcome

-The incidence of RSV-associated hospitalization from Days 1 through 150 postdose.
-The incidence of RSV-associated MALRI (outpatient and inpatient) from Days 1 through 180 postdose.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: <= 1age old
• Gender: Both

Include criteria

-Is a healthy male or female who is an early or moderate pre-term infant (>=29 to 34 weeks and 6 days gestational age) or a late pre-term or full-term infant (>=35 weeks gestational age).
-Has a chronological age >2 weeks of age up to 1 year and is entering the first RSV season at the time of obtaining documented informed consent (Phase 2b cohort only).
-Has a chronological age from birth up to 1 year and is entering the first RSV season at the time of obtaining documented informed consent (Phase 3 cohort only).

Exclude criteria

-Is recommended to receive palivizumab per local guidelines or professional society recommendations.
-Has known hypersensitivity to any component of MK-1654.
-Has a bleeding disorder contraindicating intramuscular administration.
-Has had a recent illness with rectal temperature >=100.5 F (>=38.1 C) or axillary temperature >=100.0 F (>=37.8 C) within 72 hours predose.
-Has received any vaccine or monoclonal antibody for the prevention of RSV.
-Is currently participating in or has participated in an interventional clinical study with an investigational compound or device at any time before first dose administration or while participating in this study.

Related Information

• Primary Sponsor: Kobayashi Masayuki
• Secondary ID(s): NCT04767373,2020-002405-26 ( EudraCT Number )